I do think there is a difference this time - the science has been accepted by the FDA. Last time, there was still that element of risk that maybe the FDA would reject SB on the science. The Complete Response Letter laid that concern to rest, so now the likelihood of approval has increased significantly, providing the FDA are happy with the font size of the revamped instructions!
I do think there is a difference this time - the science has...
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34.0¢ |
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